Comparative Effectiveness of Cryoablation Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cryoablation, Nerve block.
- Who it may be relevant to
- Registry conditions: Morton Neuroma. Basic parameters: 18 years — 105 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparative Effectiveness of Cryoablation Using the ICE-Seed Cryoablation Needle With Steroid and Lidocaine Versus Steroid and Lidocaine Alone for Treatment of Morton's Neuroma
Overview
Morton's neuroma is a benign thickening involving the plantar interdigital nerve, most common in middle aged women. Morton's neuroma is one of the most frequent diagnoses seen in the investigators podiatry clinic and is difficult to treat. These lesions cause a burning or shooting pain that can radiate to the toes, or an aching pain in the ball of the foot. The pain is exacerbated with activity and certain footwear greatly limits activity in the involved patient population. Morton's neuroma is first treated conservatively with orthotics. Patients may require further interventions such as steroid injections. The literature reports only a 30% long term resolution of pain with the steroid. Surgical resection has a reported 51-85% success rate with 14-21% rate of complication; recurrent pain, numbness/loss of sensation, and subsequent stump neuromas. Cryoablation is well known to be efficacious for neuropathic pain and has recently been shown in two small studies to be safe and efficacious for treatment of Morton's neuroma. The investigators study will compare outcomes of cryoablation to corticosteroid injection in short- and long-term for treatment of Morton's neuroma that have failed conservative therapy.
Interventions
- Device Cryoablation
Image (ultrasound and fluoroscopic guided) cryoablation will be performed of the Morton's neuroma after nerve block. - Procedure Nerve block
Ultrasound and fluoroscopic guided nerve block.
Primary outcome measures
- Changes in quality of life [Time frame: 1 year post procedure]
- Réponse in pain [Time frame: 1 year post procedure]
- Changes to function [Time frame: 1 year post procedure]
- Changes pain and function due to neuroma [Time frame: 1 year post procedure]
- Incidence of Treatment - Emergent Adverse Events [Time frame: 1 year post procedure]
Eligibility criteria
Inclusion criteria
- Age >18 years
- Able to consent and complete questionnaires
- Failure of a four-week trial of conservative therapy (includes orthotics, appropriate footwear, and/or metatarsal pads)
- X-ray and ultrasound excluding other pathology and confirming the presence and location of a Morton's neuroma
Exclusion criteria
- Inability to follow-up or to comply with the follow-up protocol
- Contraindication to cryoablation and/or lidocaine/steroid injection
- Other pathology which could account for symptoms identified on imaging studies
- Unwillingness to be randomized
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Oregon Health Sciences University — Portland
Identifiers
NCT: NCT05501262 · STUDY00024090